Types of Ads Subject to Mandatory Pre-Dissemination Review
The draft guidance outlines several categories of “high risk and high impact” TV ads that will be subject to mandatory pre-dissemination review under Section 503B. These include all TV ads for (1) Schedule II controlled substances and (2) drugs that are subject to a Risk Evaluation and Mitigation Strategy (“REMS”) with elements to assure safe use. Also included are the initial TV ads for: any prescription drug, a new or expanded indication for an approved prescription drug, a prescription drug after a safety labeling update to the Boxed Warning, Contraindications, or Warnings & Precautions sections, and a prescription drug after the issuance of an enforcement letter related to a TV ad for the product. Finally, FDA may designate any other types of TV ads as subject to pre-dissemination review if it finds that such review is necessary from a public health perspective (“catch-all category”). FDA will notify drug sponsors of their pre-submission review obligations either by letter or through the publication of a notice in the Federal Register.
The Pre-Dissemination Review Process
For all TV ads that fall into one of the categories identified above, sponsors will be required to submit a review package consisting of (1) a cover letter, (2) an annotated storyboard detailing the ad’s claims and the supporting references for those claims, (3) the current FDA-approved product label, and (4) a video of the ad. Additional materials may be required depending on the ad’s contents.
The sponsor must submit the review package to the appropriate FDA Center at least 45 days before it intends to disseminate the ad. The 45-day review period commences upon FDA’s receipt of a complete review package. FDA acknowledges, however, that a sponsor may wish to receive comments from the Agency before it produces a final recorded version of a TV ad. FDA will therefore permit a sponsor to submit an initial review packet that does not contain a video of the actual ad. But once the sponsor receives comments from the Agency on the not-yet-finalized review packet contents and produces a final recorded version of the ad, the sponsor still must submit the recording for pre-dissemination review. Thus, if a sponsor desires to obtain FDA’s comments prior to producing a final recording of an ad, it should consider submitting an initial review packet more than 45 days prior to the date it wishes to broadcast the ad, likely contemplating an advertisement development schedule consisting of two full 45-day review periods.
FDA plans to notify a sponsor if it will be unable to provide comments within the 45-day review period, in which circumstance the Agency will provide an estimate of the date by which it expects to provide comments. Once the 45-day clock has expired, the sponsor may choose to broadcast the ad even though it has not received comments from the Agency. The sponsor must notify FDA of such a decision, which will prompt the Agency to discontinue its 503B review of the ad. But the decision to air the ad prior to receiving FDA’s comments is not without risk. Dissemination of the ad exposes the sponsor to the potential of an enforcement action if the Agency determines that the ad is violative. It therefore may be in the sponsor’s best interests to wait for FDA’s comments on the ad, even if those comments are delayed.
Section 503B empowers the Agency to “recommend” changes to a TV ad that it deems necessary to protect the consumer good and well-being or that are otherwise consistent with the product’s prescribing information.5 FDA may also recommend the addition of statements that address the product’s efficacy in a particular population.6 Examples of specific changes that FDA might advocate include modification of the ad’s presentation of risk information and elimination of information that FDA considers false or misleading.
While a sponsor is not required to implement any changes suggested by FDA, it would be inadvisable not to. Once the changes have been made, the sponsor need not resubmit the revised TV ad, so long as the revisions directly respond to the Agency’s comments and do not introduce new claims, concepts, or creative themes. Nonetheless, sponsors who want FDA’s feedback on a revised TV ad should submit it through the voluntary advisory submission process.
Consequences of Failure to Comply
It is a prohibited act, a violation of the FDCA, to disseminate a TV ad that is subject to Section 503B without complying with the mandatory pre-dissemination review process.7 Noncompliance can result in the issuance of an injunction and/or the imposition of criminal penalties,8 as well as the enhancement of civil monetary penalties. Of course, the issuance of an enforcement letter is another potential consequence of noncompliance.
While it has been several years since FDA last issued an enforcement letter related to a TV ad, the area remains a significant source of regulatory action, even in the context of a pre-dissemination review program. In October 2008, Bayer HealthCare received a Warning Letter from the Division of Drug Marketing, Advertising, and Communications (now the Office of Prescription Drug Promotion) concerning certain TV ads for the birth control product YAZ®.9 Bayer had submitted the ads for Agency review at the time of the ads’ dissemination as required by 21 C.F.R. § 314.81(b)(3)(i). Among other things, FDA found the TV ads were misleading because the risk disclosures made during the major statement were minimized by distracting visuals, numerous scene changes, and background music, all of which made it difficult for viewers to process and comprehend the risk information being conveyed. As a result, Bayer was required to withdraw the TV ads and to submit a plan of action for disseminating corrective messages. Compliance with Section 503B’s mandatory pre-submission review process may moderate the issuance of similar enforcement letters in the future.
Opportunity To Comment
The guidance document discussed in this column is in its draft phase. Accordingly, the Agency has requested comments on it generally, as well as four specific topics related to its collection of the information called for under the draft guidance, including ways to minimize the burden of the collection of information on sponsors. But comments need not be limited to the types identified by the Agency. Other potential topics for comments might include:
- A request for additional (or any) guidance on how FDA will determine whether a TV ad falls into the catch-all category;
- Whether FDA will offer sponsors who submit TV ads for mandatory pre-dissemination review the same protections that it offers to sponsors that voluntarily submit ads for advisory comments under 21 C.F.R. § 202.1(j)(4) (i.e., whether the sponsor will have the benefit of advance notice if FDA determines during its review that the ad is not violative, but later changes its opinion); or
- Thoughts on the constitutionality, particularly under the First Amendment, of a regime that ostensibly requires FDA approval prior to broadcasting a TV ad.
FDA requests that comments to the draft guidance be submitted by May 14, 2012, so that the Agency may consider them before it begins drafting the final version of the guidance.10
- 21 C.F.R. § 314.81(b)(3)(i).
- 21 C.F.R. § 202.1(j)(4).
- 21 U.S.C. § 353b (“The Secretary may require the submission of any television advertisement for a drug (including any script, storyboard, rough, or a completed video production of the television advertisement) to the Secretary for review under this section not later than 45 days before dissemination of the television advertisement”).
- Guidance for Industry: Direct-to-Consumer Television Advertisements—FDAAA DTC Television Ad Pre-Dissemination Review Program; Draft Guidance (HHS, FDA, CDER, CBER Mar. 2012), available at http://1.usa.gov/HVldER
- 21 U.S.C. 353b(b)(1) and (2) (2008).
- 21 U.S.C. § 331(kk).
- 21 U.S.C. §§ 332(a), 333(a).
- October 3, 2008 Warning Letter to Bayer HealthCare Pharmaceuticals, Inc., available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053993.pdf.
- Draft Guidance for Industry on Direct-to-Consumer Television Advertisements—the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad Pre-Dissemination Review Program; Availability; Notice; 77 Fed. Reg. 14811 (Mar. 13, 2012).
Colleen Heisey [email@example.com] is a partner in the Washington, D.C. office of Hunton & Williams LLP in the Firm’s Food and Drug Practice. Sharon Bradley is an associate in the Firm’s Food and Drug Practice.